For in vitro diagnostic use. Others cobas Cdiff IVD cobas® Cdiff RMD-Liat-CDIFF-001 Nucleic acid test for use on the cobas® liat system 07 454 945 190 7 454 945 190 07454945190 7454945190 07454945190 KIT COBAS LIAT CDIFF IVD cobas Cdiff 00875197005677 Reagents, kits 1 pack 20 tests true US-IVD and CE-IVD The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test that uses real-time polymerase chain reaction (PCR) for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors. en The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test that uses real-time polymerase chain reaction (PCR) for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C.difficile infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for professional use in a clinical laboratory setting or point of care (POC) location as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors. en Sample preparation Organisms within the stool specimen are lysed with a chaotropic agent and proteinase K. Released nucleic acids, including Bti Internal Control DNA, are bound by magnetic glass particles. The particles are washed, and bound nucleic acids are eluted into a small volume of buffer and then mixed with Master Mix and activating co-factor for the PCR reaction. PCR amplification and TaqMan® detection The Master Mix reagent contains primer pairs and probes for C. difficile toxin B and the Internal Control. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan® probes containing a fluorescent reporter dye and a quencher. Normally, the quencher suppresses the fluorescence of the reporter dye. However, if the PCR product is present, the probe hybridizes to the product and is cleaved by the 5’- to 3’-nuclease activity of the polymerase, thereby separating the reporter dye and quencher. This reaction allows the fluorescence to be emitted from the reporter dye, and the signal is recorded in real time during each PCR cycle by the cobas® Liat® Analyzer. This signal is interpreted by the cobas® Liat® System Software and reported as final results. Selective amplification Selective amplification of target nucleic acid from the specimen is achieved in cobas® Cdiff by the use of AmpErase (uracil-N-glycosylase) enzyme and deoxyuridine triphosphate (dUTP). The AmpErase enzyme recognizes and catalyzes the destruction of DNA strands containing deoxyuridine19, but not DNA containing deoxythymidine. Deoxyuridine is not present in naturally occurring DNA, but is always present in amplicon due to the use of deoxyuridine triphosphate in place of thymidine triphosphate as one of the dNTPs in the Master Mix reagent; therefore, only amplicon contain deoxyuridine. Deoxyuridine renders contaminating amplicon susceptible to destruction by AmpErase enzyme prior to amplification of the target DNA. AmpErase enzyme, which is included in the Master Mix reagent, catalyzes the cleavage of deoxyuridine-containing DNA at the deoxyuridine residues by opening the deoxyribose chain at the C1-position. When heated in the first thermal cycling step at the alkaline pH of Master Mix, the amplicon DNA chain breaks at the position of the deoxyuridine, thereby rendering the DNA non-amplifiable. AmpErase enzyme is inactive at temperatures above 55°C, i.e., throughout the thermal cycling steps, and therefore does not destroy target amplicon. cobas® Cdiff has been demonstrated to inactivate at least 1000 copies of deoxyuridine-containing C. difficile amplicon per PCR. 19. Longo, M. C., M. S. Berninger, and J. L. Hartley. 1990. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene, 93:125-128. en

cobas^® Cdiff

Nucleic acid test for use on the cobas^® liat system

IVD

See C. diff sooner, start patient care faster

The cobas^® Cdiff is a real-time PCR test that provides accurate, on-demand results in 20 minutes for the detection of toxigenic C. diff in unformed stool specimens from patients suspected of having a C. diff infection (CDI).

cobas^® Cdiff

Empowering faster informed isolation precautions with results in just 20 minutes
Reducing the risk of missing an acute infection with enhanced toxigenic C. diff strain coverage
Expanding C. diff testing beyond the lab with complete cobas® liat system connectivity

The cobas® liat system enables definitive and rapid diagnosis, combining powerful PCR technology with fast turnaround time, 20 minutes or less, allowing sample to answer while patients wait.

cobas^® Cdiff performance

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	Sensitivity*	Specificity*
Cdiff LOD: 45-90 CFU/swab	93.5 % (95% CI: 88.1% - 96.5%)	96.4 % (95% CI: 94.6% - 97.7%)

*Compared to direct culture. CI=confidence intervals. CFU=colony forming units.

Learn more about the expanding menu of assays

IVD

cobas^® SARS-CoV-2

Inform decisions at the POC with targeted RT-PCR SARS-CoV-2 test results in 20 minutes for both asymptomatic and symptomatic individuals using the cobas® liat system.

IVD

cobas^® SARS-CoV-2 & Influenza A/B Assay

Detect and differentiate SARS-CoV-2, influenza A and influenza B in 20 minutes from a single sample and in just one RT-PCR test for use on the cobas® liat system.

IVD

cobas^® Strep A Assay

With lab-quality results in ~15 minutes, cobas® Strep A, for use on the cobas® liat system aids clinicians to make immediate, informed treatment decisions.

IVD

cobas^® Influenza A/B & RSV Assay

Diagnose and differentiate influenza A/B & RSV for effective clinical management and infection control with the POC multiplex PCR test for use on the cobas® liat system.

...

cobas^® liat system

Rapidly test, triage, and treat your patients with the accuracy, simplicity, and security needed at the point of care.

Learn more

Traditional testing methods vs. cobas^® liat system

Traditional diagnostic methods are either time-consuming, labor-intensive or inaccurate when used alone. Testing algorithms have been developed to overcome the shortcomings of individual methods. However, these algorithms are complex and can introduce delays in result reporting, which may adversely impact patient management.

Traditional testing
methods

Patient with CDI symptoms

Isolate

Collect sample and send to lab

Process with lab PCR or algo EIA

Positive results: initiate antibiotics
Negative results: admit patient without
isolation and search for symptom etiologies

cobas^® Cdiff
test

Patient with CDI symptoms

Collect sample and send to lab

The cobas® liat system provides
accurate results in only 20 minutes

Positive results: isolate and initiate antibiotics
Negative results:, admit patient without
isolation and search for symptom etiologies

See C. diff sooner with cobas^® Cdiff to transform your patient care pathway.

Relying on the fast, accurate results from cobas® Cdiff, healthcare professionals are now able to streamline CDI diagnosis to reduce unnecessary isolation, empiric use of antibiotics and to initiate appropriate infection control measures.

Intended Use

The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test that uses real-time polymerase chain reaction (PCR) for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

The cobas® liat system is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

Registration status

CE-IVD, FDA 510(K) cleared

The cobas® liat system is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

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cobas^® Cdiff